pddEtrials®
Powerful, Secure Access to Your Data
pddEtrials is a proprietary web–based clinical trials management system that provides the most intuitive, advanced, flexible, and customizable data capture solution. Utilized by ClinOps staff, site personnel and monitors, as well as Sponsors, the system is designed to be an intuitive and powerful application for site, monitor, and sponsor trial management. Deep visibility and fast access allow each group to stay in touch with their data - anytime, anywhere.
Facts:
- Fully validated and audited system
- Complete transaction history/audit trail for every data point
- Microsoft Windows 2003 OS with IIS 6 for remote web–based access
- Underlying database – Microsoft SQL 2000
- Individual user–name and password controlled
Features:
- Secure, online access
- Electronic and paper-based data capture capable
- Create customized reports
- Download study data
- View tracking reports
- Access scanned CRFs
- Review custom SAS reports
- Manage AE and SAE reporting
Major features for Sponsors, Monitors and Site personnel:
- Intuitive web–based access to all real–time data, from anywhere in the world. No need to purchase hardware or software
- 24 hour/7 day technical support
- Customized and flexible study design and build
- On–line data entry instructions at the screen and field level
- Easy navigation between studies, patients, and visit schedules
- Easy and efficient system for addressing online data queries
- Customized reporting to create and save real-time data reports in Excel
- Secure and version–controlled study documents area to access study metric reports, monitoring visit reports, SAP deliverables, etc.
- Scanned images archive for paper CRFs, DCFs and other documents.
- Ability to restrict site, monitor and other users’ access to study documents, clinical data or safety data down to the field level
- Remote monitoring capabilities
- Ability to review and monitor multiple records at one time
- Fast and direct access to individual patient records
- Ability to print eCRFs and corresponding audit log
- Valuable study metrics reports
- Operational tools and functionalities to reduce overall time to database lock
- Safety management system that allows customized email notifications and single click generation of submission ready CIOMS and MedWatch forms

